Drug · Small Molecule

Dasatinib

CI-DRUG-00000179Explore in graph →NCIt C38713 CHEMBL5416410 CIViC Approved

Regulatory

Approvals (43)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory12 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2025-08-01 (see label)	approved	Aug 1, 2025	openfda
US FDA	—	1. INDICATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. PHYRAGO is indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. PHYRAGO TM is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. ( 1 , 14 ) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. ( 1 , 14 ) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. ( 1 , 14 ) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. ( 1 , 14 ) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. ( 1 , 14 )

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 18 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	45	19	19	268	43	CA, EU, US	Jun 28, 2006	Jul 13, 2001
Non-Hodgkin Lymphoma	Phase4	Phase 4	6	4	0	20	0	—	—	Sep 17, 2007
Multiple Myeloma	Phase4	Phase 4	4	2	0	10	0	—	—	2008-02
Malignant Central Nervous System Neoplasm	Phase3	Phase 3	1	1	1	10	0

Curated evidence

Clinical evidence (319)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 301–319 of 319 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
KIT K642E1
Dasatinib	Melanoma

Clinical trials

Trials with this intervention (273)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 251–273 of 273 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT00816283	Dasatinib and Vorinostat in Treating Patients With Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia or Acute Lymphoblastic Leukemia	completed	Phase 1	5	City of Hope Medical CenterOTHER	1	Jul 17, 2012	clinicaltrials
NCT01627132	Discontinuation of Dasatinib in Patients With Chronic Myeloid Leukemia-CP Who Have Maintained Complete Molecular Remission for Two Years; Dasatinib Stop Trial

Molecule

Record

Kind: Small Molecule
Mechanism: Tyrosine-protein kinase ABL inhibitor; Platelet-derived growth factor receptor beta inhibitor; Stem cell growth factor receptor inhibitor; Ephrin type-A receptor 2 inhibitor; SRC inhibitor; Bcr/Abl fusion protein inhibitor
Targets: 15 genes
UNII: RBZ1571X5H
Aliases: 5-Thiazolecarboxamide, N-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)-1-piperazinyl)-2-methyl-4-pyrimidinyl)amino)-, Monohydrate, APO-DASATINIB, BMS 354825, BMS354825, BMS-354825-03, BMS-354825 HYDRATE, Dasatinib, Dasatinib Accord, Dasatinib accord healthcare, Dasatinib Accordpharma, Dasatinib hydrate, Dasatinib Hydrate, Dasatinib Monohydrate, NSC-759877, PHYRAGO, Sprycel, SPRYCEL, TARO-DASATINIB, TEVA-DASATINIB

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (59)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EA02	DASATINIB
DIN (Health Canada)

KIT L576P1

Dasatinib

Melanoma

Predictive

Supports Sensitivity Response

accepted

EID42

The melanoma cell line WM3211, which harbors the L576P mutation, is sensitive to dasatinib. Molecular modeling indicated the L576P mutation alters the conformation of KIT but did not alter the binding… (full text at CIViC)

PMID 19671763 · Woodman et al., 2009 · Open in CIViC

PDGFRB Fusion2
Dasatinib	Childhood B-cell Acute Lymphoblastic LeukemiaUNRESOLVED	Predictive	C	Supports Sensitivity Response	3	submitted	EID7129 A 14 month old female with normal karyotype B-ALL was found to have an atypical ATF7IP-PDGFRB fusion. At day 19 of VDLP induction, she achieved partial remission with 6.5% lymphoblasts, and a 40 mg/da… (full text at CIViC) PMID 29133777 · Zhang et al., 2017 · Open in CIViC	civic
Bafetinib + Dasatinib + Imatinib + Nilotinib + Ponatinib + RebastinibSubstitutes	Childhood B-cell Acute Lymphoblastic LeukemiaUNRESOLVED	Predictive	D	Supports Sensitivity Response	4	submitted	EID7196 In vitro studies in Ba/F3 murine cells. Cells transduced with tetracycline-inducible ATF7IP-PDGFRB were capable of proliferating in an IL-3-independent manner and had a gene expression pattern overlap… (full text at CIViC) PMID 26703895 · Ishibashi et al., 2016 · Open in CIViC	civic